Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework
| Autor: | Rajiv Mahajan, Mark Waskiewicz, Michel Chartrain, Yang Wang, Beth Junker, Mike Kosinski, Katie Ezis, Dephillips Peter A, Randy Henrickson, Brian K. Meyer, David Geer |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Quality Control
Computer science business.industry Process (engineering) media_common.quotation_subject Control (management) Pharmaceutical Science Information technology Quality by Design Manufacturing engineering Robustness (computer science) Drug Design Product Surveillance Postmarketing Humans Technology Pharmaceutical Quality (business) Bioprocess business Design for Six Sigma media_common |
| Zdroj: | PDA journal of pharmaceutical science and technology. 65(3) |
| ISSN: | 1948-2124 |
| Popis: | An initial quality-by-design (QbD) framework was assembled for biopharmaceutical product, process, and analytical development using the design-for-six-sigma (DFSS) methodology. This technique was both streamlined and efficient, which permitted development of a QbD framework with minimized team leader and member resources. DFSS also highly emphasized voice-of-the-customer, information considered crucial to development and implementation of a bioprocess QbD framework appropriate for current development needs of the organization and its regulatory environment. The bioprocess QbD final design and implementation plan was comprised of seven teams, constructed from six QbD elements plus a communication/training team. Each element9s detailed design was evaluated against internal and external established best practices, the QbD charter, and design inputs. Gaps were identified and risks mitigated to assure robustness of the proposed framework. Aggregated resources and timing were estimated to obtain vital implementation sponsorship. Where possible, existing governance and information technology efforts were leveraged to minimize additional bioprocess resources required. Finally, metrics were selected to track success of pilots and eventual implementation. LAY ABSTRACT: An initial quality-by-design (QbD) framework was assembled to guide biopharmaceutical product, process, and analytical development. QbD starts by defining the patient requirements which then are translated into required quality attributes for the product. The production process then is designed to consistently meet these quality requirements by identifying and understanding those parameters which influence them. A control strategy is developed that specifically relates each point of control to a desired quality measure. Overall, this approach results in a robust process, capable of reliably producing quality product. The bioprocess QbD framework was developed to guide implementation of the desired QbD strategy. It was comprised of seven teams, constructed from six QbD elements plus a communication/training team. Each element9s detailed design was evaluated against internal and external established best practices, the charter, and design inputs. Gaps were identified and risks mitigated to assure robustness of the proposed framework. Aggregated resources and timing were estimated to obtain vital implementation sponsorship. Where possible, existing governance and information technology efforts were leveraged to minimize additional bioprocess resources required. Finally, metrics were selected to track success of pilots and eventual implementation. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|